Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma
Randomised Phase 3 Study of Rituximab in High-Risk Patients With Diffuse Large B-Cell Lymphoma Who Received a First-Line Consolidative Chemotherapy With Autologous Stem Cell Transplant (ASCT).
調査の概要
詳細な説明
This is a multicentric, open-label, randomized clinical study, evaluating the efficacy and the safety of Rituximab After ASCT in patients aged 18 to 59 years with previously untreated High-Risk (aa-IPI 2 or 3 ) Diffuse Large B-Cell Lymphoma .
The duration of the treatment period is approximately 25 weeks and patients are followed until Death.
From 10/99 to 05/03, 476 patients were enrolled. 235 patients were assigned to receive ACE and 241 to ACVBP. Among the 331 patients, in Complete response (CR+CRu) after induction, who received HDC, 269 were randomized (R2) after hematological recovery to receive either rituximab (n=139) or nothing (n=130).
The final analysis was performed in June 2005.
研究の種類
入学
段階
- フェーズ 3
連絡先と場所
研究場所
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Créteil、フランス
- Hôpital Henri Mondor
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Paris、フランス
- Hôpital Saint louis
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Pierre-Bénite cedex、フランス
- Service d'Hématologie - Centre Hospitalier Lyon-Sud
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Rouen、フランス
- Centre Henri Becquerel
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Vandoeuvre-les-Nancy、フランス
- CHRU de Nancy Brabois
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification).
- Aged from 18 to 59 years, eligible for transplant.
- Patient not previously treated.
- Age adjusted International Prognostic Index equal to 2 or 3.
- Having previously signed a written informed consent.
- Women of childbearing potential currently practicing an adequate method of contraception.
Exclusion Criteria:
- Any other histological type of lymphoma.
- Any history of treated or non-treated indolent lymphoma.
- Central nervous system or meningeal involvement by lymphoma.
- Contra-indication to any drug contained in the chemotherapy regimens.
- Poor renal function (creatinin level>150mmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
- Poor bone marrow reserve as defined by neutrophils < 1.5 G/l or platelets < 100 G/l, unless related to bone marrow infiltration.
- Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
- Any serious active disease (according to the investigator's decision).
- HIV, HTLV1 or HBV related disease.
- Any organ transplantation before inclusion.
- Pregnant women.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
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- To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT
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二次結果の測定
結果測定 |
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- To compare response rate to induction treatments (ACVBP vs AC/ACE).
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- To evaluate response rate at the end of treatment.
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- To compare overall survival (ACVBP vs AC/ACE; Rituximab / nothing)
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- To evaluate the safety and tolerability of Rituximab
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協力者と研究者
捜査官
- スタディチェア:Corinne Haioun、Hôpital Henri Mondor, Créteil, France
出版物と役立つリンク
一般刊行物
- Haioun C, Lepage E, Gisselbrecht C, Salles G, Coiffier B, Brice P, Bosly A, Morel P, Nouvel C, Tilly H, Lederlin P, Sebban C, Briere J, Gaulard P, Reyes F. Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: final analysis of the prospective LNH87-2 protocol--a groupe d'Etude des lymphomes de l'Adulte study. J Clin Oncol. 2000 Aug;18(16):3025-30. doi: 10.1200/JCO.2000.18.16.3025.
- Coiffier B, Haioun C, Ketterer N, Engert A, Tilly H, Ma D, Johnson P, Lister A, Feuring-Buske M, Radford JA, Capdeville R, Diehl V, Reyes F. Rituximab (anti-CD20 monoclonal antibody) for the treatment of patients with relapsing or refractory aggressive lymphoma: a multicenter phase II study. Blood. 1998 Sep 15;92(6):1927-32.
研究記録日
主要日程の研究
研究開始
研究の完了
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
リツキシマブの臨床試験
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Aprea Therapeutics終了しましたマントル細胞リンパ腫 | 慢性リンパ性白血病 | 非ホジキンリンパ腫アメリカ